NCT02396030

Brief Summary

Eclampsia is an obstetric emergency capable of prophylaxis. To prevent and control seizures, there is no doubt that the magnesium sulfate (MgSO4) is the ideal drug. However, there are still questions regarding its use and dose. The scheme and the optimal time of administration remain to be elucidated. The objective of this trial is to compare the effectiveness and safety of intravenous magnesium sulfate in the maintenance phase 1g / h versus 2 g / h to prevent eclampsia in pregnant and postpartum women with severe preeclampsia (pure or superimposed).

Trial Health

57
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
62

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Mar 2015

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2015

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

March 10, 2015

Completed
14 days until next milestone

First Posted

Study publicly available on registry

March 24, 2015

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

December 20, 2016

Status Verified

December 1, 2016

Enrollment Period

1 year

First QC Date

March 10, 2015

Last Update Submit

December 19, 2016

Conditions

Preeclampsia

Outcome Measures

Primary Outcomes (1)

  • ECLAMPSIA

    Seizures that occur after the loading dose, during magnesium sulfate, until 24 hours after the delivery of the baby

    From end of loading dose, until 24 hours after delivery

Secondary Outcomes (18)

  • Placental abruption

    From end of loading dose, until delivery of the child

  • postpartum hemorrhage

    From end of loading dose, until 48 hours after delivery

  • COMPLICATIONS

    From end of loading dose, until 3 hours after delivery

  • thromboembolic complications

    From end of loading dose, until 15 days after delivery

  • liver failure

    From end of loading dose, until 15 days after delivery

  • +13 more secondary outcomes

Study Arms (2)

Magnesium sulfate 50% - 1g/h

ACTIVE COMPARATOR

After loading dose of 6g of magnesium sulfate, patients will receive the maintenance dose of 1g/hour of intravenous magnesium sulfate, for 24 hours

Drug: Magnesium sulfate 50% - 1g/h

Magnesium sulfate 50% - 2g/h

EXPERIMENTAL

After loading dose of 6g of magnesium sulfate, patients will receive the maintenance dose of 2g/hour of intravenous magnesium sulfate, for 24 hours

Drug: Magnesium sulfate 50% - 2g/h

Interventions

Magnesium sulfate 50% - 1g/hDRUG

Patients will receive after the loading dose os magnesium sulfate, the maintenance dose of 1g/hour of intravenous of magnesium sulfate for 24 hours after loading dose

Also known as: Mg SO4
Magnesium sulfate 50% - 1g/h
Magnesium sulfate 50% - 2g/hDRUG

Patients will receive after the loading dose os magnesium sulfate, the maintenance dose of 1g/hour of intravenous of magnesium sulfate for 24 hours after loading dose

Also known as: MgSO4
Magnesium sulfate 50% - 2g/h

Eligibility Criteria

Age14 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Severe Preeclampsia (pure and superimposed)

You may not qualify if:

  • Eclampsia before administration of the loading dose of MgSO4 ;
  • Use of other medications or illicit drugs that may interfere with maternal hemodynamics;
  • Contraindications to the use of magnesium sulfate: known hypersensitivity to the drug, oliguria with urine output below 25 ml per hour or anuria (urine output absent) and myasthenia gravis.
  • Use of mechanical ventilation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Instituto Materno Infantil Prof. Fernando Figueira

Recife, Pernambuco, 50.070-550, Brazil

Location

Related Publications (1)

  • Diaz V, Long Q, Oladapo OT. Alternative magnesium sulphate regimens for women with pre-eclampsia and eclampsia. Cochrane Database Syst Rev. 2023 Oct 10;10(10):CD007388. doi: 10.1002/14651858.CD007388.pub3.

    PMID: 37815037DERIVED

MeSH Terms

Conditions

Pre-Eclampsia

Interventions

Magnesium Sulfatenickelboussingaultite

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-InducedPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Intervention Hierarchy (Ancestors)

Magnesium CompoundsInorganic ChemicalsSulfatesSulfuric AcidsSulfur AcidsSulfur Compounds

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD PhD

Study Record Dates

First Submitted

March 10, 2015

First Posted

March 24, 2015

Study Start

March 1, 2015

Primary Completion

March 1, 2016

Study Completion

December 1, 2016

Last Updated

December 20, 2016

Record last verified: 2016-12

Locations

BR(1)